MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO® 3 SYSTEM; SIMILAR DEVICE FG540000, 510K # K042999

Catalog Number FG540000C

Device Problems Signal Artifact/Noise (1036); Use of Device Problem (1670); Application Program Problem (2880)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a procedure with a carto® 3 system and no signal available for the physician to monitor the patient¿s heart rhythm issue occurred.Initially, it was reported that there was a machine error 1201.The usage count of this bs cable on the machine has exceeded 100 times.There was no patient consequence reported.Both the error message and the issue of the bs cable on the machine exceeded 100 times were assessed as not mdr reportable.The most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death was remote.Additional information was received on 18-jan-2023.The "error 1201" was accompanied by a signal noise/signal loss issue.Only signal noise was present.The signal interference was observed on all ecg (bs + ic) channels and on both the carto® and recording system.No signal available for the physician to monitor the patient's heart rhythm.The affected catheter was not inside the patient¿s body during the signal interference.The bs ecg cable was not replaced and it was not out-of-box failure.The no signal available for the physician to monitor the patient¿s heart rhythm was assessed as mdr reportable.The awareness date for this information is 18-jan-2023.

Manufacturer Narrative

Requested translation for initial reporter facility name.However, no further information has been made available.The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Additional information was received on 12-apr-2023 providing the facility name of ¿zhengzhou central hospital high-tech zone hospital".Therefore, updated ¿e1.Initial reporter facility name¿.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number:(b)(6).

Manufacturer Narrative

It was reported that a patient underwent a procedure with a carto® 3 system.It was reported that there was a machine error 1201: ¿ecg limb lead disconnection¿ was displayed on the carto 3 system.The usage count of this bs cable on the machine has exceeded 100 times.There was no patient consequence reported.Additional information was received.The "error 1201" was accompanied by a signal noise/signal loss issue.Only signal noise was present.The signal interference was observed on all ecg (bs + ic) channels and on both the carto® and recording system.No signal available for the physician to monitor the patient's heart rhythm.The affected catheter was not inside the patient¿s body during the signal interference.The investigation was completed on 15-oct-2023.It was confirmed that the issue was resolved by replacing the faulty bs cable with another one that was delivered to the customer.The issue was resolved.The system is ready for use.Replaced bs ecg cable was sent to the device manufacturer for investigation and repair.It was found that the cable causes error 1201 be appeared on the carto screen.Mechanical impact on the cable, probably caused by extended use, caused this kind of damage.The complaint history of the system was reviewed and no more similar problems were found since the issue occurred.The system is ready for use.A manufacturing record evaluation was performed for the system # 66664, and no internal actions related to the reported complaint condition were identified.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: CARTO® 3 SYSTEM
• Type of Device: SIMILAR DEVICE FG540000, 510K # K042999
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16383877
• MDR Text Key: 309636178
• Report Number: 2029046-2023-00308
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FG540000C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN BRAND CATHETER; UNKNOWN BRAND RECORDING SYSTEM